In the United States, HIV incidence is growing most rapidly among young men who have sex with men (YMSM). More than 20% of all new HIV infections in the United States are among young people aged 13-24 years, and 92% of these new infections are diagnosed in YMSM, making them one of the largest risk groups for HIV [1]. Men who have sex with men (MSM) of color are disproportionately impacted by the epidemic; in 2015, significantly more black MSM were diagnosed with HIV than white MSM, despite the relatively lower numbers of black MSM overall. HIV diagnoses among young Latino MSM have increased by 14% [1]. Importantly, it is estimated that compared with the general population, a higher proportion of YMSM (13% vs 44%, respectively) living with HIV do not know that they are infected [2,3] and, thus, will incur a delay seeking effective treatment, making it more likely that they will transmit HIV to others.

Overwhelming evidence demonstrates that routine testing, resulting in early identification, and therefore, early treatment, of HIV infection, and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV as well as improve health outcomes for those who are infected [4-8]. However, HIV testing and use of PrEP among young adults is suboptimal. While at least biannual HIV testing is recommended for sexually active MSM, data suggest that approximately 60% of YMSM do not get even annual HIV tests [9]. Moreover, uptake of PrEP has remained low [10], particularly among young people. In a national Web-based survey of MSM, only 6% of those aged 18-24 years had ever used PrEP compared with 18% of those in the 30+ age group [11].

The normal developmental trajectory of adolescence and young adulthood involves behavioral experimenting, risk taking, and confronting a host of difficult choices with regard to identity formation [12]. These age-appropriate behaviors, beliefs of invincibility, and still-developing cognitive processes may play a role in increasing HIV risk taking behaviors and in placing a low priority on HIV testing and uptake of prevention strategies, particularly PrEP, which requires taking a daily pill to be effective [13].

The ongoing and growing HIV risk for YMSM highlights the need to reach younger individuals using developmentally appropriate, innovative methods and modalities. In addition to expanding access to effective prevention modalities, innovative methods to reach YMSM “where they are” must be developed. Smartphone use is nearly universal among youth in the United States [14]. Younger adults, racial and ethnic minorities, and socioeconomically disadvantaged populations have been identified as having high rates of smartphone use, reducing concerns of inequitable access to the technology [15]. The use of mobile phone apps is ubiquitous and is a common way in which youth interact, get information, and meet sex partners. Mobile apps offer unique opportunities for public health interventions, including efforts to increase HIV testing and PrEP uptake, particularly for YMSM, who may be open to receiving information in a familiar and discreet environment.

Although the popularity of mobile health apps is growing, there are limited data on the efficacy of app-based interventions to enhance HIV prevention and increase HIV testing among MSM, particularly YMSM. However, formative research suggests that Web-based, mobile, or social media outlets are acceptable and feasible means to increase the uptake of prevention services and HIV testing among MSM [16-20]. Informed by extensive formative research, Dr. Patrick Sullivan of Emory University (one of iTech’s Principal Investigators), together with app developers from Keymind, developed and tested an HIV testing promotion app for adult MSM (HealthMindr) [21]. Our initial formative research with YMSM [22] suggested interest in the basic functionalities of an HIV testing app like HealthMindr, but the youth felt that it would not be culturally and developmentally appropriate for their peers without further development. As a result, MyChoices incorporates youth feedback to realize an app that draws on the HIV testing functionality of HealthMindr but has been significantly redesigned in the following ways: (1) sexual health information presented in a simple, streamlined, and integrated fashion; (2) designed with attention to having a youth-friendly, social media style appeal; and (3) reduction of text by employing icons, graphics interchange formats (GIFs), and videos.

The MyChoices app is informed by the social cognitive theory (SCT), which specifies goal setting, self-efficacy, and self-regulation as essential influences of health behavior [23,24]. SCT holds that cognition, behavior, and environmental influences interact with one another and reinforce one another to impact health behavior (Figure 1).

For example, self-regulatory functions (eg, self-monitoring one’s HIV testing through development of testing plans) and self-efficacy (eg, belief that one can attain the goal to test regularly) are enhanced by facilitative environmental conditions [23,24] such as reminder systems. MyChoices uses multimedia capabilities and environmental influences to support self-regulation and self-efficacy by enhancing the feeling of control over one’s ability to get tested regularly for HIV and use PrEP. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos, and infographics as well as “Help me Choose” (a quiz to help recommend a preferred setting for HIV testing), “Ordering” (a Web-based store to order free condoms, condom-compatible lubricant, and at-home HIV test kits), and geofencing (using global positioning system [GPS] to notify users when they are near a test site and due for testing) functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP.

The aim of this paper is to describe the protocol for the refinement of an HIV prevention mobile app, beta testing it, and conducting a pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app for YMSM. We hypothesize that participants who are randomized to use the MyChoices app will report that the app is highly acceptable and will use the main functions of the app over the follow-up period. We also hypothesize that while not powered to detect significant differences, MyChoices users will report taking more HIV tests and increasing PrEP uptake compared with YMSM receiving the control condition.

To refine and enhance the MyChoices app for HIV testing and PrEP uptake among YMSM, we will conduct 4 theater testing groups with approximately 30 YMSM. Testing will take place at 2 iTech subject recruitment venues (SRVs; Boston, MA, and Bronx, NY), and groups will provide suggestions and feedback to improve app acceptability and feasibility as well as approaches to HIV prevention [25]. We aim to have 5-8 participants per group in order to balance the need to have an intimate enough group to share insights, yet large enough to ensure diversity of opinions [26,27]. Participants will be HIV-uninfected YMSM aged between 15 and 24 years who have not had a recent HIV test. For 15-17-year olds, participants must also self-report any anal sex with a male or transfemale partner. For 18-24-year olds, participants must self-report at least one of the following in the past 6 months:

From our prior experience in recruiting YMSM, we found that it is necessary to include YMSM who engage in lower sexual risk (eg, anal sex with condoms) for the younger age group. Given that risk changes over time, we will still be enrolling an at-risk population who could benefit from the app and who should be testing for HIV regularly.

Prior to theater testing, participants will complete a brief demographic and behavioral questionnaire in order to contextualize the group data. During theater testing, participants will be asked to interact with the MyChoices app, and feedback will be elicited on the overall appearance and functionality of the app interface, appeal, and usability; ways to maximize acceptability (eg, update language, improve flow, etc); components they like and/or dislike; and areas for improvement. Guided by the SCT model, we will specifically obtain insight into the functionalities and content aimed at impacting self-regulation, self-efficacy, and environmental influences as they relate to HIV prevention.

Theater testing groups will last 60-90 minutes, and discussions will be audiorecorded and transcribed verbatim. Facilitators will also take notes and complete standardized debriefing forms immediately following the visit. These data will allow us to make final refinements to the app, as well as the intervention protocol and assessment battery, prior to initiation of the open technical evaluation and RCT pilot.

After refinement as described above, the MyChoices app will undergo beta testing with a small group of YMSM participants (up to 15 YMSM at 2 iTech SRVs: Boston, MA, and Bronx, NY) over a 2-month period. Using the same criteria as Phase 1, participants will be HIV-uninfected young cisgender MSM aged between 15 and 24 years who have not had a recent HIV test and self-report evidence of risk for acquiring HIV infection. For this phase, participants will also be required to own or lease an Android phone, as MyChoices will only be available on an Android platform during beta testing until it is coded by the same developers in iOS for the pilot RCT. This delay is meant to reduce the cost of recoding multiple versions of the edited app. Besides the slight native differences and system-specific limitations between the two platforms, the app was designed in such a way that the visual elements, capabilities, and interactions would be as similar as possible across both platforms.

All participants will be given brief instructions on the purpose of the MyChoices app and an overview of how to use it. Because the primary objective of the beta testing phase is to test instruments and procedures to be used in the pilot RCT, participants will complete the same assessments and processes to be used in the pilot RCT (see pilot RCT section for details). In brief, we will assess acceptability of the MyChoices app using the System Usability Scale (SUS) [28], and feasibility will be assessed using app analytics to determine whether the app was used and what functionalities were most likely and least likely to be opened. Participants will also be asked to provide feedback during Web-based exit interviews conducted by study staff using a Health Insurance Portability and Accountability Act-compliant videoconferencing software (VSee; VSee Lab, LLC, Sunnyvale, CA) technology. Feedback will be requested on functionality, technical performance, errors and software bugs encountered, overall experiences using the app, feedback for further refinement, and subjective impact of the app on HIV testing and PrEP uptake.

A rapid analysis of the data from the exit interviews will be conducted using the detailed notes taken on the debrief forms [29]. The study team will meet to discuss themes that emerged in the qualitative exit interviews, usage patterns, and acceptability ratings. We will triangulate the findings in order to refine the app, intervention protocol, and assessment tools prior to the pilot RCT [30].

The primary analyses will summarize acceptability (mean score on the SUS) and feasibility (participants utilizing the app at least once during follow-up) of the app, overall for the intervention arm, with asymptotic normal 95% CIs. Point estimates for mean acceptability ≥50 and for proportion accessing the app >0.60 will be considered the minimum criteria for acceptability and feasibility, consistent with industry standards [28,32].

The primary efficacy analysis will compare HIV testing (defined by the proportion that self-reports at least 1 HIV test result during follow-up) between the study arms at 3- and 6-month follow-ups. Group differences in self-reported PrEP-related appointments and documented HIV test results will also be examined at each time point. Moreover, group differences in measures related to the SCT model constructs (eg, HIV testing self-efficacy) will be assessed. The distribution of all variables will be assessed, and appropriate tests will be conducted (ie, parametric chi-square test vs nonparametric Fisher’s exact test).

All analyses will use two-tailed tests of significance, with significance at alpha=.05. We will follow an intent-to-treat approach [52], analyzing participants in the study arm to which they were assigned. We will examine the equivalence of random assignment to groups with regards to key baseline characteristics, including sociodemographics, prior HIV testing patterns, and sexual risk-related variables. In the event that randomization does not work to balance these characteristics, we will assess whether baseline differences may account for differences in outcomes.